CLASS II Device recall · Reported 12 May 2021 · FDA Enforcement Report

LeverEdge Contrast Injector: 35 cc syringe recalled by LeMaitre Vascular

LeMaitre Vascular is recalling LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock, distributed nationwide in the US. The recall was initiated on 6 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099

Quantity recalled616 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1529-2021
FDA event ID: 87689
Recalling firm: LeMaitre Vascular, Burlington, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Apr 2021
FDA classified: 4 May 2021
Reported: 12 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Syringes & Needles

Timeline

6 Apr 2021	Recall initiated by company
4 May 2021	Classified by FDA	+28 days
12 May 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

Product as listed by the FDA

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.

Nationwide Alabama California Florida Illinois Indiana Kentucky Massachusetts Missouri New York Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

Which lots are affected?

Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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